Acute Renal InjuryNCT04600271
Acute Renal Injury After Major Elective Non-Cardiac Surgery
An observational study of Acute Renal Injury, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The study is planned to be a single-center study and includes patients who underwent major surgery within Istanbul University Istanbul Faculty of Medicine with an invasive arterial line. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Injury
- What is being tested?
- Crystalloid Solutions, Colloid Blood Volume Expanders and blood replacement
- How many people
- 425 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone non-cardiac major surgery in Istanbul University Faculty of Medicine will be included in the study.
Who may be able to join
- Age of ≥18 years
- Patients who are ASA I-III
- Patients who have undergone major noncardiac surgery
- Patients who need post-operative intensive care follow-up due to major surgery or long surgery
- Patients diagnosed with CKD but do not need routine hemodialysis
Who cannot join
- Age of <18 years
- Patients who have undergone minor surgery
- Surgeries which lasts <30 minutes
- Patients who will be hospitalized less than two days postoperatively
- Patients who need routine hemodialysis due to CKD
- Patients who had renal transplantation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine Departmant of Anesthesiology and Reanimation
Istanbul, 34093
About this study
Official title: Risk Factors of Acute Kidney Injury After Major Elective Non-Cardiac Surgery : A Prospective Observational Study
The study is planned to be a single-center study and includes patients who underwent major surgery within Istanbul University Istanbul Faculty of Medicine with an invasive arterial line. Our aim to define the incidence of acute renal injury in our setting and to investigate the risk factors listed in detailed description. After obtaining written informed consent from the patients, preoperative risk factors will be notes. Following standard anesthesia monitoring as well as routine anesthesia induction and maintenance, invasive arterial monitoring will be performed due to the major surgery and hemodynamic values will be recorded throughout the surgery. The primary outcome will be acute renal injury based on KDIGO's (Kidney Disease: Improving Global Outcomes) definition of acute renal damage. Postoperative data regarding this outcome as well as additional data listed in detailed description will be collected.
Read the detailed description
The study is a single-center study that observes patients who undergo major abdominal surgery within Istanbul University Istanbul Faculty of Medicine.
Standard anesthesia monitoring (NIBP, SPO2(oxygen saturation by pulse oximetry), ECG) will be applied to the patients taken to the operation room. Routine anesthesia induction and maintenance will be performed by the anesthetist responsible for the patients. After anesthesia induction, invasive arterial monitoring will be performed.
Our data collection and recording will be as follows: preoperative, intraoperative, postoperative.
In the preoperative section;
- Age, gender, height, weight, BMI of the patient
- ASA (American Society of Anesthesiologists) classification, additional diseases and functional capacity
- Drugs used (ACE-İ, ARB (angiotensin receptor blocker), Statin, B-blocker, NSAID)
- Entry creatinine and eGFR (estimated glomerular filtration rate) calculated with CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
- Entry hemoglobin, lymphocyte, CRP (C reactive protein)
- The presence of ascites in the abdomen
In the intraoperative section;
- Surgery (gynecological oncology surgery, gastrointestinal surgery, genitourinary surgery) and its duration
- Applied form of anesthesia (general-regional)
- Liquids given during the operation (Crystalloid (isotonic, isolyte, lactated ringer), colloid, albumin) and their amounts oNoradrenaline requirement
- Use of diuretic, NSAID
- Blood transfusion
- Total amount of bleeding during the operation
- First arterial blood gas electrolytes taken due to routine major surgery
- The lowest amount of hemoglobin seen during the operation
- Routine invasive artery monitorization due to major surgery, and mean arterial pressure In the postoperative section;
- Requirement of intensive care
- Blood transfusion requirement
- Noradrenaline requirement
- Use of diuretic and NSAID
- Electrolyte values in the first blood gas taken routinely
- Creatinine value immediately after the surgery and at 24th and 48th hours
- First 48-hour urine output The diagnosis of acute renal injury is based on KDIGO's definition of acute renal damage. By analyzing from this information, significant risk factors for acute renal damage are identified and measures are taken against them.
- Conditions
- Acute Renal Injury
- Being tested
- Crystalloid Solutions, Colloid Blood Volume Expanders, blood replacement, Diuretic, noradrenaline
- Keywords
- colloids, mean arterial blood pressure
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalloid SolutionsDrug
exposure
Colloid Blood Volume ExpandersDrug
exposure
blood replacementOther
exposure
DiureticDrug
exposure
noradrenalineDrug
exposure
Non-Steroidal Anti-Inflammatory AnalgesicsDrug
exposure
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery. Receives: Drug: Crystalloid Solutions; Drug: Colloid Blood Volume Expanders; Other: blood replacement; Drug: Diuretic; Drug: noradrenaline; Drug: Non-Steroidal Anti-Inflammatory Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute renal injury
Acute renal injury description will be made with KDIGO criteria.
Measured: 48 hours
Secondary outcomes (5)
Hospital stay
Will be noted as days.
Measured: 30-90 days
ICU stay
Will be noted as days.
Measured: 30-90 days
Chronic Kidney Disease
will be noted after postoperative period.
Measured: up to 1 year
Mortality
will be noted in the hospital period.
Measured: 30-90 days
Complication after surgery
will be noted in the hospital period.
Measured: 30-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Jun 2019
- Primary completion1 Nov 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Renal InjuryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilan Büyük, Istanbul University
- Investigators
- Mukadder Orhun Sungur, Assos. Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600271
- Sponsor's protocol ID
- 2019/747
- Status last verified
- Sep 2021
- First submitted
- 11 Oct 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hobson C, Ruchi R, Bihorac A. Perioperative Acute Kidney Injury: Risk Factors and Predictive Strategies. Crit Care Clin. 2017 Apr;33(2):379-396. doi: 10.1016/j.ccc.2016.12.008.
PubMed 28284301Goren O, Matot I. Perioperative acute kidney injury. Br J Anaesth. 2015 Dec;115 Suppl 2:ii3-14. doi: 10.1093/bja/aev380.
PubMed 26658199Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
PubMed 26181335
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Acute Kidney Injury After Major Elective Non-Cardiac Surgery : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04600271
- Acronym / sponsor ID
- 2019/747
- Conditions
- Acute Renal Injury
- Keywords
- colloids, mean arterial blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is planned to be a single-center study and includes patients who underwent major surgery within Istanbul University Istanbul Faculty of Medicine with an invasive arterial line. Our aim to define the incidence of acute renal injury in our setting and to investigate the risk factors listed in detailed description. After obtaining written informed consent from the patients, preoperative risk factors will be notes. Following standard anesthesia monitoring as well as routine anesthesia induction and maintenance, invasive arterial monitoring will be performed due to the major surgery and hemodynamic values will be recorded throughout the surgery. The primary outcome will be acute renal injury based on KDIGO's (Kidney Disease: Improving Global Outcomes) definition of acute renal damage. Postoperative data regarding this outcome as well as additional data listed in detailed description will be collected.
Detailed description
The study is a single-center study that observes patients who undergo major abdominal surgery within Istanbul University Istanbul Faculty of Medicine.
Standard anesthesia monitoring (NIBP, SPO2(oxygen saturation by pulse oximetry), ECG) will be applied to the patients taken to the operation room. Routine anesthesia induction and maintenance will be performed by the anesthetist responsible for the patients. After anesthesia induction, invasive arterial monitoring will be performed.
Our data collection and recording will be as follows: preoperative, intraoperative, postoperative.
In the preoperative section;
- Age, gender, height, weight, BMI of the patient
- ASA (American Society of Anesthesiologists) classification, additional diseases and functional capacity
- Drugs used (ACE-İ, ARB (angiotensin receptor blocker), Statin, B-blocker, NSAID)
- Entry creatinine and eGFR (estimated glomerular filtration rate) calculated with CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
- Entry hemoglobin, lymphocyte, CRP (C reactive protein)
- The presence of ascites in the abdomen
In the intraoperative section;
- Surgery (gynecological oncology surgery, gastrointestinal surgery, genitourinary surgery) and its duration
- Applied form of anesthesia (general-regional)
- Liquids given during the operation (Crystalloid (isotonic, isolyte, lactated ringer), colloid, albumin) and their amounts oNoradrenaline requirement
- Use of diuretic, NSAID
- Blood transfusion
- Total amount of bleeding during the operation
- First arterial blood gas electrolytes taken due to routine major surgery
- The lowest amount of hemoglobin seen during the operation
- Routine invasive artery monitorization due to major surgery, and mean arterial pressure In the postoperative section;
- Requirement of intensive care
- Blood transfusion requirement
- Noradrenaline requirement
- Use of diuretic and NSAID
- Electrolyte values in the first blood gas taken routinely
- Creatinine value immediately after the surgery and at 24th and 48th hours
- First 48-hour urine output The diagnosis of acute renal injury is based on KDIGO's definition of acute renal damage. By analyzing from this information, significant risk factors for acute renal damage are identified and measures are taken against them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Drug: Crystalloid Solutions, Drug: Colloid Blood Volume Expanders, Other: blood replacement, Drug: Diuretic, Drug: noradrenaline, Drug: Non-Steroidal Anti-Inflammatory AnalgesicsPatients over the age of 18 and who undergone major elective non-cardiac abdominal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone non-cardiac major surgery in Istanbul University Faculty of Medicine will be included in the study.
Key inclusion criteria (5 listed)
- Age of ≥18 years
- Patients who are ASA I-III
- Patients who have undergone major noncardiac surgery
- Patients who need post-operative intensive care follow-up due to major surgery or long surgery
- Patients diagnosed with CKD but do not need routine hemodialysis
Key exclusion criteria (6 listed)
- Age of <18 years
- Patients who have undergone minor surgery
- Surgeries which lasts <30 minutes
- Patients who will be hospitalized less than two days postoperatively
- Patients who need routine hemodialysis due to CKD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crystalloid Solutionsexposure | Drug | Study Group |
| Colloid Blood Volume Expandersexposure | Drug | Study Group |
| blood replacementexposure | Other | Study Group |
| Diureticexposure | Drug | Study Group |
| noradrenalineexposure | Drug | Study Group |
| Non-Steroidal Anti-Inflammatory Analgesicsexposure | Drug | Study Group |
Primary outcome
Acute renal injury
Time frame: 48 hours
Acute renal injury description will be made with KDIGO criteria.
5 secondary outcomes
Hospital stay
Time frame: 30-90 days
ICU stay
Time frame: 30-90 days
Chronic Kidney Disease
Time frame: up to 1 year
Mortality
Time frame: 30-90 days
Complication after surgery
Time frame: 30-90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Background: PubMed 28284301Hobson C, Ruchi R, Bihorac A. Perioperative Acute Kidney Injury: Risk Factors and Predictive Strategies. Crit Care Clin. 2017 Apr;33(2):379-396. doi: 10.1016/j.ccc.2016.12.008.
- Background: PubMed 26658199Goren O, Matot I. Perioperative acute kidney injury. Br J Anaesth. 2015 Dec;115 Suppl 2:ii3-14. doi: 10.1093/bja/aev380.
- Results publication: PubMed 26181335Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mukadder Orhun Sungur, Assos. Prof. study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Injury, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute renal injury (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600271, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.